DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-18, 21, 23, and 24 are pending and examined on the merits.
Claim 1 is amended.
Claim 24 is new.
Claims 19-20 are cancelled.
Claim 22 is amended but was previously withdrawn for being drawn to non-elected species.
Response to Amendment
Applicant amendments filed 07/21/2025 have been fully considered.
Response to Arguments
Applicant provided amendments to the independent claims which necessitates a new ground of rejection. Accordingly, Applicant’s arguments filed 07/21/2025 have been fully considered. Regarding Applicant’s arguments, Examiner respectfully submits that the arguments rely on a previous interpretation of the previously cited prior art references and are thus moot. Examiner directs Applicant to the rejections below for an explanation on why the amendments do not overcome the prior arts of reference. Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1), Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), Seres (U.S. Pre Grant Pub. No. 2019/0133810 A1), Stroebech (U.S. Pre Grant Pub. No. 2017/0079576 A1), and Lai (U.S. Pre Grant Pub. No. 2017/0098044 A1), Taub (U.S. Pre Grant Pub. No. 2014/0200426 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented via the amendments.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18, 21, 23, and 24 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method, performed in an accessory device, for determining, based on a threshold of a change criterion relating to a risk of future leakage, whether an operating state satisfies a change criterion.
This judicial exception is not integrated into a practical application at least because the method does not specifically require providing an accessory device, an ostomy appliance, and/or a monitor device as recited in the preamble. The method steps do not amount to significantly more as they are merely steps of acquiring data and showing it on a screen, which is a display of an abstract concept. There is no requirement that the method step assists in changing of the base plate or any other structure and is merely directed to determining and displaying of a recommendation of changing. Accordingly, the preamble is considered to be a field of use and does not require additional elements. The method steps require:
obtaining monitor data comprising an electrical property of a region of an adhesive layer of the base plate;
processing the electrical property to generate an operating state of the ostomy appliance, indicating adhesive performance;
determining whether the operating state satisfies the change criterion; and
in accordance with the operating state satisfying the change criterion, displaying, on the display, a first user interface screen comprising a first user interface object comprising a graphical representation of the ostomy appliance, and transforming the monitor data from the monitor device into the graphical representation that indicates a required change of the base plate to address the risk of future leakage
In reevaluating the claims in Step 2B (see MPEP 2106(III)), the elements of the display on the screen and the accessory device appear to be a generic computer. The accessory device discussed on page 3 lines 28-31 of Applicant’s specification is given as a general computer such as mobile phone, other handheld device, a wearable such as an electronic watch, or a docking station, thus, this invocation merely amounts to the process being performed on a general computer. Additionally, a general computer generally requires a processor, an input device, and a display. Therefore, the display is not significantly more and is well understood, routine, and conventional.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), and further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1).
Regarding claim 1, Thirstrup teaches: a method, performed in an accessory device, for assisting change of a base plate of medical appliance (see for example para. [0151]), wherein the accessory device (see for example event-handling device 103 in Fig. 8A) comprises an interface (see for example para. [0151]) configured to communicate with one or more devices of a medical system (para. [0151], for example, teaches that the event-handling device 103 sends a signal to a service center; see also references 105 and 116 in Figs. 8A and 8B, respectively), the interface comprising a display (see unlabeled display on event-handling device 103 in Fig. 8A), wherein the ostomy system comprises a monitor device (see unlabeled monitor in reference 105 in Fig. 8A), and/or a medical appliance (see for example para. [0018]) configured to be placed on a skin surface of a user (see for example Fig. 1A and para. [0107]), wherein the medical appliance comprises a base plate (see for example para. [0018]), the method comprising:
- obtaining, from the monitor device, monitor data comprising an electrical property of a region of an adhesive layer of the base plate (para. [0077] teaches that the multiple electrodes on an adhesive is advantageous for detection of a leak; and that each time the leak is below a particular electrode, a capacitance change related to that electrode may be detected; as broadly recited, a region of an adhesive layer of the base plate can be considered to be an entirety of the adhesive layer or a part of the adhesive layer);
- processing the electrical property of the monitor data to generate an operating state of the ostomy appliance indicating adhesive performance of the ostomy appliance (para. [0153], for example, teaches that the sensor response of a leak sensor for an adhesive is determined when a leak occurs; para. [0154] discloses that a sensor response is determined when the adhesive absorbs moisture, thereby affecting its performance; in addition, the Abstract discloses that the invention of Thirstrup is for a method of detecting detachment of an ostomy device);
- determining, based on a threshold of a change criterion (para. [0149, 0152] teach that when a threshold is exceeded, a reader sends a wireless signal to a handling device, such as a PC, that informs a health care professional that a change of bandage/dressing is necessary), whether the operating state satisfies a change criterion (para. [0018] teaches that an alarm is activated when changes in capacitance reach a predetermined value); and
- in response to determining the operating state satisfies the change criterion:
- displaying, on the display, a first user interface screen comprising a first user interface object representing the operating state indicative of a required change of the base plate (see at least para. [0151]).
However, while Thirstrup teaches that the wireless signal can be a graphical representation (see numeral 116 in Fig. 8B), Thirstrup does not explicitly teach generating a graphical representation of the ostomy appliance based on the generated operating state and comprising a moisture pattern representation at least partially shaped according to the region of the adhesive layer, or that the display displays a first user interface object comprising a graphical representation of the ostomy appliance representative of the wear property thereby transforming the monitor data from the monitor device into the graphical representation that indicates a required change of the base plate to address the risk of future leakage, as required by the claim.
Angelides teaches an analogous method for providing comprehensive care for stoma patients (see Abstract) comprising a medical user application (see software application 210 in Fig. 3). Angelides further teaches an application on a mobile device that provides a visual representation of one or more parameters representing the operating state of the ostomy appliance, which may include graphs or charts (see for example para. [0115] and Figs. 7A-B) representative of the wear property of the adhesive layer of the base plate (as broadly recited, leakage will break down the adhesive which will affect the wear property and operating state of the ostomy appliance). Angelides further teaches a parameter sensor in the form of a paper that can be used to measure leakage when the paper gets wet and report this to a communicator (see at least para. [0061]) which stores and transmits the measurements measured by the parameter sensor such that the measurements are communicated, recorded, and tracked (see para. [0049]) which are displayed as a visual representation that include graphs or charts (see para. [0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thirstrup to incorporate the teachings of Angelides by generating a graphical representation of the ostomy appliance based on the generated operating state and comprising a moisture pattern representation at least partially shaped according to the region of the adhesive layer and/or displaying on the display a first user interface object comprising a graphical representation of the operating state of the ostomy appliance at least to allow a user to quickly and easily decipher the operating state of the ostomy device, as taught by Angelides (see at least para. [0115]).
Krystek teaches an analogous method for assisting change of an ostomy device comprising displaying on a computing device a user interface object indicative of remaining wear time and/or an estimated time window for change to prevent leakage (see at least Abstract and para. [0034]). Krystek further teaches tracking sensor data to collect historical conditions and events which can be used to predict wear times, future failures, likely full times (see at least para. [0029]) due to a wear property of the adhesive performance (para. [0013] teaches that the loss of adhesivity is a condition that is monitored by the device).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup in view of Angelides to incorporate the teachings of Krystek by modifying the ostomy device to determine, based on a threshold of a change criterion relating to a risk of future leakage, whether the operating state satisfies the change criterion, and displaying a graphical representation of the operating state indicative of a required change of the base plate to address the risk of future leakage at least because by addressing the risk of future leakage, an accurate picture can be created for estimated remaining life of the appliance, thereby providing the patient with a proactive, predictive tool to avoid failures, leaks, and unexpected full conditions, which in turn will relieve anxiety, avoid embarrassment, and benefit the health of the patient as well as public health by allowing bag changes under appropriate conditions, as taught by Krystek (see para. [0029]).
Regarding claim 2, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, while Thirstrup does not explicitly teach the step of opening a medical user application in response to detecting a first input selecting the user interface object, as required by the claim, Thirstrup teaches that the event-handling device 103 transfers signals to a service center where a medical professional is notified to change a medical appliance. Therefore, one of ordinary skill in the art would have reasonably recognized that an intermediate step must be present where the medical professional opens a computer software in response to receiving an electronic notification regarding a medical event, such as a leak in a base plate of a medical appliance. In addition, the step of opening an application in response to an input is well known in the art and one of ordinary skill in the art would have been motivated to modify the method of Thirstrup, in view of Angelides, and further in view of Krystek to include the step of opening a medical user application in response to a first input at least because most software applications on current “smart devices” (such as smartphones, smartwatches, tablet devices…etc.) allow for the opening of the application in response to detecting an input from a user. For example, a user tapping/clicking on a notification generated by an application on their smart device would cause that application to open. Such a modification is reasonably within the capability of one of ordinary skill in the art.
Regarding claim 3, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 2. However, Thirstrup fails to explicitly teach displaying a second user interface screen indicative of the required change of the base plate, as required by the claim.
Angelides teaches that several messages can be sent via a portal 240 to alert a user that immediate change of an ostomy device is needed (see para. [0086]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to further incorporate the teachings of Angelides by displaying one or more messages that alerts a user of the required change of the ostomy device at least in order to provide comprehensive care for a stoma patient, as taught by Angelides (see Abstract).
Regarding claim 4, Thirstrup, in view of Angelides, and further in view of Krystek teach the invention as discussed above in claim 3. However, neither Thirstrup nor Angelides explicitly teach displaying a third user interface object indicative of a remaining wear time and/or estimated time window for change, as required by the claim.
Krystek teaches a method for assisting change of an ostomy device comprising displaying on a computing device a user interface object indicative of remaining wear time and/or an estimated time window for change to prevent leakage (para. [0034], for example, teaches that an application program may process retrieved sensor data and predict when the ostomy device should be replaced in order to avoid failure).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup in view of Angelides to further incorporate the teachings of Krystek by displaying in the second user interface screen a third user interface object indicative of a remaining wear time and/or an estimated time window for change to prevent leakage at least in order to notify a wearer of when to change their ostomy device, as taught by Krystek (see para. [0034]). Additionally, one of ordinary skill in the art would have been motivated to further incorporate the teachings of Krystek with the method of Thirstrup, in view of Angelides, and further in view of Krystek at least in order to avoid failure of the ostomy device, as taught by Krystek (see para. [0034]).
Regarding claim 5, Thirstrup, in view of Angelides, and further in view of Krystek teach the invention as discussed above in claim 3. However, neither Thirstrup nor Angelides explicitly teach displaying a fourth user interface object indicative of an estimated elapsed wear time of the base plate, as required by the claim.
Krystek teaches a smart device, such as a smart phone, and an application program collects, analyzes, and present data to the patient and can send historical data indicating wear time to a computing cloud (see para. [0029] and [0035]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to further incorporate the teachings of Krystek by displaying in the second user interface screen a fourth user interface object indicative of an estimated elapsed wear time of the base plate at least because Krystek teaches that ostomy appliances have maximum wear times beyond which the appliances are likely to fail (see for example para. [0013]). With the teachings of Krystek in hand, one of ordinary skill in the art would have reasonably recognized that alerting a user of the elapsed wear time of the ostomy device would be beneficial to the user as it allows them to better predict when a change of the ostomy device would be required
Regarding claim 6, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 3. However, while Thirstrup does not explicitly teach displaying a fifth user interface object indicative of a battery status of the monitor device, as required by the claim, such a step is well known in the art and one of ordinary skill in the art would have been motivated to modify the method of Thirstrup to include a step of displaying the battery status of a monitor device at least in order for a user to determine when to charge the monitor device. Such a modification is reasonably within the capability of one of ordinary skill in the art. In addition, prior art references exist which teach the claimed method step.
Further, Angelides teaches displaying a user interface object indicative of a hardware parameter of the monitor device, the hardware parameter comprising a battery status of the monitor device (see for example unlabeled battery status indicator in Figs. 7A-C).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to further incorporate the teachings of Angelides by displaying in the second user interface screen a fifth user interface object indicative of a hardware parameter of the monitor device, the hardware parameter comprising a battery status of the monitor device, at least in order better advise a patient of needed action, as taught by Angelides (see Abstract).
Regarding claim 7, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, while Thirstrup does not explicitly teach displaying a fourth user interface object or detecting a second input, as required by the claim, Thirstrup teaches that when a leak is detected, a visual indicator is displayed informing the user and/or medical professional to change their ostomy device (see para. [0151]). Therefore, one of ordinary skill in the art would have reasonably recognized that one or more intermediate steps must be present. For example, prior to the step of displaying a visual indicator informing the user to change their ostomy device, one or more steps must be performed, such as, a notification is sent to and displayed on a medical professional’s electronic device and an input selecting the notification is detected by the electronic device.
Regarding claim 9, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 7. However, while Thirstrup does not explicitly teach displaying a second prompt indicating to the user to apply a new base plate, as required by the claim, Thirstrup teaches that when a leak is detected, a visual indicator is displayed informing the user and/or medical professional to change their ostomy device (see para. [0151]). Therefore, one of ordinary skill in the art would have reasonably recognized that Thirstrup at least impliedly teaches an intermediate step of displaying a prompt to apply a new base plate.
Regarding claim 24, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. Additionally, Thirstrup teaches wherein the region is defined between an electrode pair of the base plate (para. [0077] teaches that the multiple electrodes on an adhesive).
Claims 8, 11, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), as applied to claim 7 above, and further in view of Seres (U.S. Pre Grant Pub. No. 2019/0133810 A1).
Regarding claim 8, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 7. However, Thirstrup fails to explicitly teach that the monitor device is removed from the base plate, as required by the claim.
Angelides teaches that a measurement communicator 530 can be removably attached to an ostomy device. However, neither Thirstrup, Angelides, nor Krystek explicitly teach displaying a first prompt indicating to the user to remove the monitor device from the used base plate, as required by the claim.
Seres teaches an analogous ostomy monitoring method comprising an ostomy bag, a wafer, sensors, and an electronics hub that transmits data from the sensors to a backend system 170 connected a computer cloud (see at least para. [0216]). The data is then transmitted to a computer application on a display (see para. [0346]) which informs a user of the status of the ostomy device (see para. [0187]). Seres also teaches that the hub is removed from an ostomy device that is about to be disposed and then be used on a subsequent new ostomy device (see para. [0301]) and that notifications can be sent to a user alerting them to replace reusable hubs (see para. [0349]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to further incorporate the teachings of Angelides by removably attaching the monitor device to the base plate at least in order for the monitor device and the base plate to enable and disable communication between sensors located in the base plate and the monitor device, as taught by Angelides (see para. [0052]). In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Seres by including a step of displaying a first prompt indicating to the user to remove the monitor device from the used base plate at least in order for notifications to be sent to a user alerting them to replace the monitor device by first removing the monitor device from the base plate that is about to be disposed of, as taught by Seres (see para. [0349]).
Regarding claim 11, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 7. However, Thirstrup does not explicitly teach that the monitor device is attached to the new base plate, as required by the claim.
Angelides teaches that a measurement communicator 530 can be removably attached to an ostomy device. However, neither Thirstrup, Angelides, nor Krystek explicitly teach displaying a first prompt indicating to the user to remove the monitor device from the used base plate, as required by the claim.
Seres teaches an analogous ostomy monitoring method comprising an ostomy bag, a wafer, sensors, and an electronics hub that transmits data from the sensors to a backend system 170 connected a computer cloud (see at least para. [0216]). The data is then transmitted to a computer application on a display (see para. [0346]) which informs a user of the status of the ostomy device (see para. [0187]). Seres also teaches that the hub is removed from an ostomy device that is about to be disposed and then be used on a subsequent new ostomy device (see para. [0301]) and that notifications can be sent to a user alerting them to replace reusable hubs (see para. [0349]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to further incorporate the teachings of Angelides by removably attaching the monitor device to the base plate at least in order for the monitor device and the base plate to enable and disable communication between sensors located in the base plate and the monitor device, as taught by Angelides (see para. [0052]). In addition, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Seres by including a step of displaying a third prompt indicating to the user to attach the monitor device to the new base plate at least in order for notifications to be sent to a user alerting them to replace the monitor device by attaching the monitor device to the new base plate, as taught by Seres (see para. [0349]).
Regarding claim 23, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, neither Thirstrup, Angelides, nor Krystek teaches that the graphical representation of the operating state of the ostomy appliance comprises a moisture pattern representation of the ostomy appliance, as required by the claim.
Seres teaches that a method of detecting an ostomy leak (see, for example, para. [0057]) can include determining a moisture content of adhesives on an adhesive layer of the wafer (see at least para. [0061]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Seres by making the graphical representation of the operating state of the ostomy appliance comprise a moisture pattern representation of the ostomy appliance at least because Seres teaches that the moisture content of the adhesives is indicative of the level of attachment/detachment of the ostomy wafer to the skin of a user, as taught by Seres (see at least para. [0061]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), as applied to claim 7 above, and further in view of Stroebech (U.S. Pre Grant Pub. No. 2017/0079576 A1).
Regarding claim 10, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 7. However, neither Thirstrup, Angelides, nor Krystek teaches the method step of capturing an image of a peristomal area of a user, as required by the claim.
Stroebech teaches an analogous method and device for use on a wound, stoma, fistula, or stoma wafer site (see at least Abstract), comprising the method step of capturing images of a peristomal skin of a user (see para. [0062]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Stroebech by including the step of capturing an image of peristomal area of a user at least in order to improve the quality of examination of ostomy sites and/or worn ostomy wafers, as taught by Stroebech (see for example para. [0007]).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), as applied to claim 1 above, and further in view of Lai (U.S. Pre Grant Pub. No. 2017/0098044 A1).
Regarding claim 12, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, neither Thirstrup, Angelides, nor Krystek appear to teach the method step of displaying a sixth user interface object indicating that the medical system is operational, as required by the claim.
Lai teaches an analogous method for assisting change of a medical pad comprising the step of determining whether a change of the medical pad satisfies a dryness criterion (see para. [0160]) and notifying a medical professional indicating that the medical system is operational (Id.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Lai by including the step of determining whether the change of base plate satisfies a success criterion, and in accordance with the determination that the change of base plate satisfies the success criterion, displaying a sixth user interface object indicating that the medical system is operational at least in order to alert a user that a medical professional has indeed replaced the base plate, as taught by Lai (see para. [0159]).
Regarding claim 13, Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai teaches the invention as discussed above in claim 12. However, neither Thirstrup, Angelides, nor Krystek appear to teach that the success criterion comprises a primary success criterion that is satisfied when the monitor device is connected properly to the base plate, as required by the claim.
Lai teaches that electronic signals are sent to a server informing a user that the sensor module is properly connected to the medical pad (see para. [0160]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai to further incorporate the teachings of Lai by satisfying a primary success criterion when the monitor device is connected properly to the base plate at least in order for a medical professional to know that the monitor device is properly working, as taught by Lai (see para. [0160]).
Regarding claim 14, Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai teaches the invention as discussed above in claim 12. However, neither Thirstrup, Angelides, nor Krystek appear to teach that a secondary success criterion is satisfied when the monitor device is connected properly to the accessory device, as required by the claim.
Lai teaches that a notification is sent to a nurse station when a new sensor module 34 is attached to the medical device (see para. [0157]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai to further incorporate the teachings of Lai by satisfying a secondary success criterion when a monitor device is connected properly to the accessory device at least in order to alert a medical professional that the device is properly connected, as taught by Lai (see para. [0157]).
Regarding claim 15, Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai teaches the invention as discussed above in claim 12. However, neither Thirstrup, Angelides, nor Krystek appear to teach that the success criterion is satisfied when the primary and secondary success criterions are satisfied, as required by the claim.
Lai teaches that electronic signals are sent to a server informing a user that the sensor module is properly connected to the medical pad (see para. [0160]) and that a notification is sent to a nurse station when a new sensor module 34 is attached to the medical device (see para. [0157]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai to further incorporate the teachings of Lai by satisfying the success criterion when the primary and secondary success criterions are satisfied at least in order to alert a medical professional that the device is properly connected, as taught by Lai (see para. [0157] and [0160]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), further in view of Lai (U.S. Pre Grant Pub. No. 2017/0098044 A1), as applied to claim 12 above, and further in view of Taub (U.S. Pre Grant Pub. No. 2014/0200426 A1).
Regarding claim 16, Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai teaches the invention as discussed above in claim 12. However, neither Thirstrup, Angelides, Krystek, nor Lai appear to teach displaying the sixth user interface object on a home screen and/or lock screen.
Taub teaches an analogous method for monitoring medical devices comprising a monitoring device that may include software (see para. [0217]). Taub further teaches that various user interface objects can be displayed on the home screen of the device, including providing the status of a medical device placed on a patient (Id.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai to incorporate the teachings of Taub by including the step of displaying the sixth user interface object on a home screen, and/or on a lock screen at least in order for the home screen to function as a reference point to perform various functions or features on the device, as taught by Taub (see for example para. [0224]).
Regarding claim 17, Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai teaches the invention as discussed above in claim 12. However, neither Thirstrup, Angelides, nor Krystek, nor Lai appear to teach displaying the sixth user interface object in a third user interface screen of a medical user application, as required by the claim.
Taub teaches that the monitoring device provides various graphical user interfaces (GUIs) or screens that are displayed to assist the user with operation of the device or provide information to the user (see para. [0219]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, further in view of Krystek, and further in view of Lai to incorporate the teachings of Taub by displaying the sixth user interface object in a third user interface screen of a medical user application at least in order to assist the user with operation of the device or provide information to the user, as taught by Taub (see para. [0219]).
Claim 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Thirstrup (U.S. Pre Grant Pub. No. 2017/0340474 A1) in view of Angelides (U.S. Pre Grant Pub. No. 2017/0140103 A1), further in view of Krystek (U.S. Pre Grant Pub. No. 2013/0324952 A1), as applied above to claim 1, and further in view of Taub (U.S. Pre Grant Pub. No. 2014/0200426 A1).
Regarding claim 18, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, neither Thirstrup, Angelides, nor Krystek appear to teach that the first user interface screen comprises a lock screen of the accessory device, and/or a home screen of the accessory device, as taught by the claim.
Taub teaches an analogous method for monitoring medical devices comprising a monitoring device that may include software (see para. [0217]). Taub further teaches that various user interface objects can be displayed on the home screen of the device, including providing the status of a medical device placed on a patient (see para. [0217]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Taub by including a first user interface screen that comprises a lock screen of the accessory device, and/or a home screen of the accessory device at least in order for the home screen to function as a reference point to perform various functions or features on the device, as taught by Taub (see for example para. [0224]).
Regarding claim 21, Thirstrup, in view of Angelides, and further in view of Krystek teaches the invention as discussed above in claim 1. However, neither Thirstrup, Angelides, nor Krystek appear to teach determining a status of a medical inventory and displaying one or more user interface objects representative of the status, as required by the claim.
Taub teaches that the monitoring device provides various graphical user interfaces (GUIs) or screens that are displayed to assist the user with operation of the device or provide information to the user (see para. [0219]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Thirstrup, in view of Angelides, and further in view of Krystek to incorporate the teachings of Taub by determining a status of a medical inventory of the user and displaying on a fourth user interface screen one or more user interface objects representative of the status at least in order to assist the user with operation of the device or provide information to the user, as taught by Taub (see para. [0219]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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